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An Open-label Study to Identify Molecular Markers of Steroid Resistance

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasal Polyps

Intervention: mometasone furoate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Daniel Hamilos, MD, Principal Investigator, Affiliation: Mass General Hospital

Overall contact:
Lauren Tracy, BA, Phone: 617-643-2262, Email: letracy@partners.org

Summary

Aim 1: To assess steroid sensitivity to mometasone furoate (MF) in cultured nasal polyp explant tissue in vitro. Aim 2: To assess steroid sensitivity in vivo in each subject by comparing symptom scores, nasal endoscopic findings before and following 4 weeks of treatment with mometasone furoate nasal spray (MFNS) and by comparing tissue immunohistology in NP biopsies pre- and post-treatment withA MFNS. Aim 3: To characterize the molecular signature of gene mRNA expression in "steroid-sensitive" and "steroid-resistant" NP using microarray on NP tissue pre- and post-MFNS treatment. Hypothesis 1: Genes that regulate apoptosis are dysregulated in nasal polyp (NP) inflammatory cells, epithelial cells and smooth muscle actin myofibroblasts leading to persistence of inflammatory cell infiltration and abnormal epithelial and myofibroblast cellular proliferation. These can be corrected by mometasone. Apoptosis-regulating genes that cannot be corrected by mometasone are upregulated in steroid-resistant NP. Elucidation of this dysregulation may prove insightful in understanding the mechanism of action of mometasone in NP and identifying potential molecular targets that will increase steroid sensitivity or, conversely, overcome steroid resistance. Hypothesis 2: There is a molecular signature of gene expression in NP that signifies steroid sensitive NP (SS-NP). This signature is altered in steroid resistant NP (SR-NP). Elucidation of differences in the molecular signature of SS-NP versus SR-NP before and after treatment with mometasone furoate (MFNS) will provide novel insight into treatment of NP with steroids.

Clinical Details

Official title: An Open-label Study to Identify Molecular Markers of Steroid Resistance in Nasal Polyposis Before and Following Treatment With Mometasone Furoate (MFNS) 2 Sprays/Nostril (100 Mcg/Nostril) Twice Daily for 4 Weeks.

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Steroid Sensitivity in vivo

Molecular Signature of mRNA

Steroid sensitivity in vitro

Eligibility

Minimum age: 21 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The subject must fulfill all of the following conditions or characteristics to be

considered for enrollment:

1. Male or female between ages 21 - 70 years residing in the Boston area

2. History of chronic rhinosinusitis (symptoms for at least 3 months). Subject must have two or more of the following:

- Facial pain/pressure or headache

- Nasal congestion

- Anterior or posterior nasal drainage

- Hyposmia/anosmia

3. Abnormal CT scan in at least 2 sinuses areas within 3 months 4. Evidence of bilateral polyps or polypoid mucosa (on nasal endoscopy) with minimum polyp/polypoid score of 4 (see scoring system below). Exclusion Criteria:

- 4. History of suggestive of immunodeficiency (i. e. those who have had > one

pneumonia in the past 12 months or those with known immune deficiency). 5. History of cystic fibrosis, Kartagener's syndrome, immotile cilia syndrome, hypogammaglobulinemia or bleeding disorder 6. URI within six weeks prior to enrollment 7. Intranasal cocaine use 8. Pregnancy (if applicable 9. History of fainting MEDICATION EXCLUSIONS prior to NP biopsies: 10. Use of prescription blood thinners 11. Use of systemic glucocorticoids for two weeks prior to enrollment 12. Use of intranasal corticosteroids and anticholinergics for three days prior to enrollment 13. Use of an antibiotic for three days prior to enrollment 14. Use of antihistamines for one week prior to enrollment

Locations and Contacts

Lauren Tracy, BA, Phone: 617-643-2262, Email: letracy@partners.org

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Lauren Tracy, BA, Phone: 617-643-2262, Email: letracy@partners.org
Daniel Hamilos, MD, Principal Investigator
Additional Information

Starting date: July 2013
Last updated: January 17, 2014

Page last updated: August 23, 2015

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